# FDA 483 - Ajinomoto Althea, Inc. - February 09, 2023

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/580fc4cc-211e-489a-8466-337a0c433bff

> FDA 483 for Ajinomoto Althea, Inc. on February 09, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2023-02-09
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Ajinomoto Althea, Inc. in San Diego, a biological drug product manufacturer, was inspected by the FDA from February 2-9, 2023. The inspection revealed significant deficiencies across multiple areas, primarily concerning aseptic processing controls, quality unit responsibilities, and laboratory controls. Key issues included inadequate smoke studies, poor aseptic techniques, lack of data integrity controls, and untimely deviation management, indicating a potential compromise to product sterility and overall quality assurance.

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## Related Officers

- [Esther C. Broner](https://www.keypedia.com/people/esther-c-broner/5df7ca72-a21f-4586-a5e0-8a782045281c)
- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.keypedia.com/companies/ajinomoto-althea-inc/75fb5ea8-b86f-45c1-946e-80c73765f544

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd